Eminent Spine’s additively manufactured pedicle screw receives FDA 510(k) approval
May 13, 2025
Eminent Spine, based in Plano, Texas, USA, has achieved FDA 510(k) approval for its additively manufactured titanium pedicle screw. These small screws are used in spinal fusion surgeries, placed in the spinal column to provide extra strength and stability while the fusion surgery heals.
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Eminent Spine’s cannulated and fenestrated pedicle screws feature a self-tapping tip to optimise insertion. The cortical/cancellous hybrid thread pattern with triple-lead threading was chosen for improved fixation.
The additively manufactured screws come in 6.0, 6.5, 7.0, 7.5, and 8.0 mm diameters, with lengths from 40-60 mm. They are compatible with 5.5 mm straight or contoured rods, polyaxial tulips, cross connectors and a comprehensive universal instrumentation set.
This follows the FDA 510(k) approval of Eminent Spine’s SI Screw System in 2024.
